This
web seminar presents content and impact discussion of the FDA and Office of
Human Research Protections (OHRP) Adverse Event reporting guidance documents.
The guidance documents address issues of Adverse Event information exchange
between stakeholders and propose solutions to the issues of the quality of
information being sent to the IRBs. The guidance impacts the activities of the
research site, IRB, and sponsor/CRO’s role in compiling and/or communicating
Adverse Event information during a research study, changing the industry’s
current practices.
- Appreciate the changing regulatory climate and
the impact on safety reporting in clinical trials
- Explain the global response and
recommendations for more meaningful safety reporting between stakeholders
- Describe the FDA’s response: January
2009 Final Guidance
- Describe the OHRP’s response:
January 2007 Final Guidance
- Recognize implications for current
practices
- Examine case scenarios
- Sites: Principal Investigators, Clinical Research
Coordinators, Managers
- Sponsors: Clinical Research
Associates, Sponsor Clinical Operations, Safety Information Specialists,
Regulatory Professionals
Elizabeth
Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
$625
Includes up to 20
participants at one site. All participants (up to 20) are eligible for
“Certificates of Attendance,” and accreditation, provided that accreditation
requirements are met. For groups larger than 20 or for additional sites, please
call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 1.5 hours (0.15 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-19-040-L01-P.
Released: 10/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.